Regulatory Affairs Officer

2 - 4 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Gepach International

time outline icon Pithampur, Madhya Pradesh, India

Posted on 07-11-2024

186 Views

1 Vacancy

Description

Assess new and existing products to ensure ongoing compliance with applicable regulations throughout their lifecycle, including post-market surveillance and reporting.
Advise internal teams (R&D, Marketing, Manufacturing) on regulatory requirements, product claims, and labeling to ensure compliance with regulatory standards.
Serve as the primary point of contact between the company and regulatory authorities, addressing any inquiries or requests from agencies.
Participate in meetings with regulatory agencies to discuss submission strategies, approval processes, or product issues.
Respond to regulatory queries, providing additional data or clarifications as needed.
Provide regulatory support throughout the product development lifecycle, including pre-market, post-market, and product withdrawal or discontinuation processes.
Coordinate the preparation of regulatory documentation for product changes, manufacturing site changes, or variations.
Monitor and track regulatory developments and emerging trends that may impact the company’s products and provide strategic recommendations to the business.
Review product labeling, marketing materials, and advertising to ensure that all claims comply with regulatory guidelines.
Ensure consistency between product claims and regulatory requirements across different regions or countries.